FDA.reportPublic FDA data

HAND SANITIZER - ISOPROPYL ALCOHOL ANTISEPTIC

Manufacturer
MAREK HEWRYK LLC
Effective date
2020-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:30

Label at a glance#

ProductHAND SANITIZER - ISOPROPYL ALCOHOL ANTISEPTIC 75 PERCENT
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Dosage and administration

PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACES. RUB HANDS TOGETHER UNTIL DRY. SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING.

Storage and handling

STORE BETWEEN 15-30 C (59-86F) AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ISOPROPYL ALCOHOL 75% W/V

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USE(S)

INDICATIONS & USAGE SECTION

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE

  • IN CHILDREN LESS THAN 2 MONTHS OF AGE
  • ON OPEN SKIN WOUNDS

WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACES. RUB HANDS TOGETHER UNTIL DRY.
  • SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • STORE BETWEEN 15-30 C (59-86F)
  • AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

GLYCERIN, HYDROGEN PEROXIDE, PURIFIED WATER USP, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, CARBOMER, TOCOPHERYL ACETATE (VIT. E), ANTHEMIS NOBILIS (CHAMOMILE) EXTRACT, TILIA CORDATA (LINDEN) EXTRACT, FRAGRANCE (PARFUM)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand-Sanitizer-Front-LabelHand-Sanitizer-Front-Label

hand-sanitizer-back label-hand-sanitizer-back label-

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2285607isopropyl alcohol 75 % Topical GelPSN1
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD1
2285607isopropyl alcohol 75 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75161-101-112022-01-28C16284748780-1d6a99b39-bf86-a426-e053-dadaa90af4c2HAND SANITIZER - ISOPROPYL ALCOHOL ANTISEPTIC 75%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75161-101-11HAND SANITIZER - ISOPROPYL ALCOHOL ANTISEPTIC75 PERCENT250 mL in 1 BOTTLEGEL2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75161-101HAND SANITIZER - ISOPROPYL ALCOHOL ANTISEPTIC 75 PERCENT (ISOPROPYL ALCOHOL) GEL [MAREK HEWRYK LLC]1Legacy NDC, 1 package rows20200505_72ade838-5c6a-434a-a69a-e60dc76a3435.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75161-10175161-101-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
TILIA CORDATA FLOWERCFN6G1F6YKIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cf011da7-dcdb-4ffc-a51c-6de5a0dda47272ade838-5c6a-434a-a69a-e60dc76a34352020-05-04WarningsExact identifier
spl id: cf011da7-dcdb-4ffc-a51c-6de5a0dda472
spl set id: 72ade838-5c6a-434a-a69a-e60dc76a3435

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.